Public Use in 1840

[A]s to the supposed public use of Wyeth’s machine before his application for a patent. To defeat his right to a patent, under such circumstances, it is essential, that there should have been a public use of his machine, substantially as it was patented, with his consent.

If it was merely used occasionally by himself in trying experiments, or if he allowed only a temporary use thereof by a few persons, as an act of personal accommodation or neighbourly kindness, for a short and limited period, that would not take away his right to a patent. To produce such an effect, the public use must be either generally allowed or acquiesced in, or at least be unlimited in time, or extent, or object. On the other hand, if the user were without Wyeth’s consent, and adverse to his patent, it was a clear violation of his rights, and could not deprive him of his patent.

As Greg “I Use My Real Name” DeLassus continues to bury non-patent law links in his comments (as if this were in any way a proper forum for such — and to be perfectly clear, it is not), maybe the following link would actually be helpful to Greg’s patent law point:

1. A method for the treatment of a hepatitis C virus infection, comprising administering an effective amount of a purine or pyrimidine β-D-2′-methylribofuranosyl nucleoside or a phosphate thereof, or a pharmaceutically acceptable salt or ester thereof.

A couple of starting thoughts for discussion:

– how is that of the 7 Wands factors, only one is agreed upon?;

– is “effective amount” a quasi-‘functional‘ claim element (describing a desired result, not the ‘how” to get there)? – while certainly the claim construction indicated an “objective physical limitation,” there certainly was no single “objective physical limitation” and the “Ladder of Abstraction” used here was certainly questionable in regards to the Wands factors;

– can this be considered to be a single “means” (in the form of step-for) claim (only one action in the method: administering) – despite the preamble being taken as a limiting element, the limit does not change the nature of a method claim with but a single step, expressed as a desired result, and was not this the type of thing that “single means claim” prohibition was meant to address?;

– In addition to the discussion of possession at page 21 (focusing more on the sheer number aspect), was possession of the effectiveness had at time of filing (as the term of “effectiveness” incurs the ability to pass effectively the requirements of human consumption), or is what was filed merely a ‘research plan?’

+ from the decision: “This conclusion is supported by the ’597 patent itself, which discloses enormous quantities of 2′-methyl-up nucleosides that would need to be tested for efficacy against HCV.” – this certainly sounds like a research plan.

+ from the decision (emphasis added): “There is no dispute that neither the ’597 patent nor any of its predecessor applications discloses a 2′-methyl-up 2′-fluoro-down nucleoside, including in any formulas or examples. See J.A. 37102–03 (admission of Idenix’s inventor). Nor is there any dispute as to why. Idenix “only came up with the methyl up fluoro down embodiment a year or so after the application was filed.” See J.A. 25562 (admission of Idenix’s counsel).”

++ Does this not sound in the very idea that I have oft put forth in regards to possession discussions of Pharma patents?

Because level of skill can be made to cut both ways – A patentee wants high skill because that requires less effort to bridge any teaching gap. A challenger wants high skill because they know of multiple disparate techniques which cloud the way forward.

It’s ultimately a moot point. There’s caselaw that says that the Wands factors are instructive, not mandatory, and Genentech requires the specification itself to enable the novel functionality. It’s not about whether one of skill could figure out what treats Hep C, its only about whether the specification teaches them that. (Although one will notice that that standard essentially makes enablement like a suped up WD)

– is “effective amount” a quasi-‘functional‘ claim element (describing a desired result, not the ‘how” to get there)? – while certainly the claim construction indicated an “objective physical limitation,” there certainly was no single “objective physical limitation” and the “Ladder of Abstraction” used here was certainly questionable in regards to the Wands factors;

– can this be considered to be a single “means” (in the form of step-for) claim (only one action in the method: administering) – despite the preamble being taken as a limiting element, the limit does not change the nature of a method claim with but a single step, expressed as a desired result, and was not this the type of thing that “single means claim” prohibition was meant to address?;

There is structure in the claim, simply insufficient structure to achieve the functionality. That’s why the court had to discuss the number of alternatives (i.e. 7000 possible structures that would need to be tested if they perform the function) rather than simply stating that it covered all possible structures. It’s not clear to me how non-limiting the structure is, but if it results in “billions and billions” then it violates the logic of the single means claim if not the letter.

– In addition to the discussion of possession at page 21 (focusing more on the sheer number aspect), was possession of the effectiveness had at time of filing (as the term of “effectiveness” incurs the ability to pass effectively the requirements of human consumption), or is what was filed merely a ‘research plan?’

Every claim to a genus not entirely possessed can be characterized as a research plan, so yes.

Idenix “only came up with the methyl up fluoro down embodiment a year or so after the application was filed.” See J.A. 25562 (admission of Idenix’s counsel).”

Well shucks, its almost like if you don’t have a rule requiring a specification to provide an embodiment and explain every inductive leap it takes instead of just taking a max-abstraction functional claim as a starting point, this could happen in every application in which counsel is not too stupid to blow the case. Certainly the law intends for this outcome to happen in every case where the attorney does not admit against his client’s interests.

Seriously though, this exact blog had a post entitled something like “WD Requires the specification to have some species representative of the infringers product” years ago. It’s Abbvie I want to say?

++ Does this not sound in the very idea that I have oft put forth in regards to possession discussions of Pharma patents?

It isn’t just pharma patents.

———————————-

Not sure why Greg or you think this is a watershed case. This is pretty basic 112(a). Does it just not get applied? (I can understand the consternation if it doesn’t get applied)

I realize your comment double-posted, but let me respond to a couple of your comments here (thanks by the way for picking up the discussion).

As to the Wands factors, you comment on the one that both sides agreed to. My point though was to the opposite effect: why were 6 of the factors NOT agreed to?

As to whether or not the factors are moot, meh, that does not change the discussion of the factors at a higher level.

I also have to pause with your comment of “one will notice that that standard essentially makes enablement like a suped up WD” – the conflation of the two requirements is an unsettled point of law (notwithstanding what the courts have stated). I have put up questions comparing and contrasting the requirements as they tie to possession (the third leg of that stool). Those questions for discussion were not picked up.

“There is structure in the claim, simply insufficient structure to achieve the functionality…. then it violates the logic of the single means claim if not the letter. ”

As to whether or not a claim is a Single Means claim does not depend on whether or not there is structure in the claim (and does not depend on whether or not the separate legal question of whether or not the structure is sufficient to achieve the functionality. Similar to Greg, here you appear to confuse the 112(f) demarcation (sufficiency to not invoke 112(f)) with other points of law.

“Every claim to a genus not entirely possessed can be characterized as a research plan, so yes.”

I am going to have to reject your attempt to translate the research plan line of legal logic to the possession in view of genus/species line of logic. Not possessing simply does NOT equate to the application being a research plan. One may easily comprehend a situation in which possession is not only absent, but the hint of “research plan” is also absent. Don’t confuse or conflate what some may call as “Wish” patents with “Research Plan” patents.

“Well shucks, its almost like if you don’t have a rule requiring a specification to provide an embodiment and explain every inductive leap it takes”

Again, I see where you want to go, but that is not what the law provides. In this instance then, your reply is a non-sequitor to the point provided.

“in every case where the attorney does not admit against his client’s interests.”

Hmm, not sure where you want to go with the notion that this particular instance is driven by some type of “attorney mistake.”

“It isn’t just pharma patents.”

But the discussion point is precisely here in the context of Pharma patents – and if you recall, several Pharma folk took exception to my point of view. I posted the point to elicit those Pharma people who had disagreed with me, and invite them to discuss this point provided.

My point though was to the opposite effect: why were 6 of the factors NOT agreed to?

Because nobody is going to concede enablement, as that controls validity. Because (even though they are only supposed to be guideposts) the Wands factors are used as the entire enablement analysis, conceding any factor is possibility conceding Wands and therefore enablement. The only reason one point happened to be agreed upon is because both sides thought it helped their Wands argument.

Similar to Greg, here you appear to confuse the 112(f) demarcation (sufficiency to not invoke 112(f)) with other points of law.

No – there is no 112(f) invocation in a non-combination. The logic goes like this: It doesn’t matter whether you claim a structure performing a function or “means for” performing a function when there is no combination. 112(f) on its face only applies to combinations. So regardless of how you word it, a single element defined by a function claims all manners of achieving that function (because the structure from the spec CANNOT be read into the claim, because 112(f) CANNOT apply). Then (and here’s the legal presumption) because the scope is directed to “all ways” of achieving the function and the specification at most discloses “this inventor’s way” of achieving the function, you will necessarily have a scope of enablement issue.

“Single means” is used to refer to the times that a claim to functionality is limiting on a single element, as opposed to a time when the element nominates sufficient structure for performing the function. i.e. A flying car is a single means claim. A car for driving is not, because the nominated structure (car) is known to perform the function (driving) conventionally. There is no scope of enablement problem with “a car for driving” so single means logic doesn’t apply. Conversely, “a flying car” is a scope (because 112(f) doesn’t apply) that applies to all mechanisms that cause a car structure to fly, not just the ones disclosed in the spec (again, the only thing that would limit the function to the spec would be to apply 112(f) logic, which you can’t apply), and therefore the claim is overbroad of the disclosed teaching.

In the instant case, there’s debate about whether the claim references 7000 structures or a billion (based upon the strength of the functional language and what is taught). Regardless of how much weight one assigns to the functionality the scope of the teaching in the spec is clearly insufficient, so it’s kind of irrelevant whether this is a single means claim or not.

Not possessing simply does NOT equate to the application being a research plan. One may easily comprehend a situation in which possession is not only absent, but the hint of “research plan” is also absent. Don’t confuse or conflate what some may call as “Wish” patents with “Research Plan” patents.

Sure, it could be entirely devoid of a disclosure such that it was new matter. But everything beyond that is a “research plan” just of varying definiteness. “A compound for treating Hep C” with no further disclosure is a research plan, just not a very good one. It would exclude, for example, research into surgical methods for treating Hep C. It might seem like common sense to start with a starting point that excludes surgical methods, but that doesn’t mean it isn’t a starting point. Either you fully grasp a solution, or you come up short on a solution. If you’re coming up short, then the work you’ve done so far is a “road map” or a “research plan” for reaching the conclusion, even if it’s not very good, and even if it entirely fails – since it tells you what NOT to do.

Again, I see where you want to go, but that is not what the law provides. In this instance then, your reply is a non-sequitor to the point provided.

I take issue with “that is not what the law provides.” Prior to ’52, claims to results absent limitations on particular means of achieving the results either always failed 112(b) or the judicial exceptions. In other words, there was no such thing as limiting by function. Either the limitations in the claim recited a structure that performed a result or they did not.

Then ’52 allowed for means-plus claimings which allowed the words of the claim to recite a function, but actual construction of the claim required importing the structure from the specification. i.e. There still is no situation where a construed claim is limited by functional result.

Post-’52, no supreme court opinion has challenged this logic. The federal circuit obviously challenged this logic, because it ignored 112(b) and the judicial exceptions. But it became clear that this was untenable, as there are a host of genuses of acts that a POSITA is enabled to do, but does not really assert a solution. So the federal circuit created WD, which the Supreme Court has never endorsed as a test.

There’s simply nothing that suggests that the rule is not “species + expanding principle = validity” while “species + unsupported genus jump = invalid.” This is entirely in keeeping with WD, because WD requires disclosure of “sufficient species to prove the breadth of the genus” and failing to disclose an expanding principle to make the inductive species-to-genus leap would definitely seem to be leaving out some breadth of the genus (see Lizardtech, Abbvie).

The end result is this – If your spec only fully grasps a bow, you can’t ever find a gun infringing of a valid scope, even if they fall under some kind of functionally similar genus. Either you are failing to define the invention with reasonable certainty, or you’re relying upon an abstraction, or you have failed to enable and posit the full breadth of the scope. Taking one working species, immediately expanding it to its utility, and then writing a specification where the working species is an example embodiment of a genus defined by the utility is not a new trick, and it has been consistently rebuffed for 150 years. It may *appear* to not be the law because right now it’s only policed by WD, and few WD claims are brought (mostly because most defendants are themselves guilty of the same kind of impropiety the patentee is) so it is rarely highlighted, but it is indeed the law.

This is just such a case – The patentee discovered OH in certain positions would achieve a result (fighting HepC), immediately called that one embodiment of a claim that has the function of fighting HepC as a limiting feature, and then tried to sue someone that had F instead when the patentee himself didn’t know if F would work.

Hmm, not sure where you want to go with the notion that this particular instance is driven by some type of “attorney mistake.”

Well it should go without saying that it is damaging to your client to tell the court that your client did not actually posit the defendant’s embodiment until after the critical date. That obviously suggests a lack of positing on the critical date. While you’re not required to prove positing of the particular infringing device, you ARE required to prove positing the breadth of the invention.

I do not think that we are in agreement on the basic definition of “Single Means” claims – as that term was used in the era of the Act of 1952.

You want this term to mean: ““Single means” is used to refer to the times that a claim to functionality is limiting on a single element, as opposed to a time when the element nominates sufficient structure for performing the function” – but that is NOT so. THAT is the 112(f) meaning of the term.

I “get” that this is a bit nuanced, as the term is used in both situations, so here, I can cut you some slack on your confusion.

“so it’s kind of irrelevant whether this is a single means claim or not.”

As an end result in this example, perhaps – as a discussion point of the law that is applied to this example, most definitely not.

“Sure, it could be entirely devoid of a disclosure such that it was new matter. ”

Nope – you jumped into the weeds, as my counter example has nothing whatsoever to do with new matter.

“A compound for treating Hep C” with no further disclosure is a research plan, just not a very good one. ”

Nope again – you cannot expand “research plan” to be anything and add the caveat of that anything merely being “not a very good one.” Your use of the term “research plan” is far far far too broad. And that’s kind of the point that I was making.

“Either the limitations in the claim recited a structure that performed a result or they did not.”

Simply wrong. Sure there were cases trying to make that a universal point of law, but there were cases that did not accord. Much like today’s mess, the Judicial Branch was trying to put their thumb on the scale. It’s amazing how you cannot seem to grasp that the Act of 1952 was in large part driven AGAINST the actions of the Supreme Court.

History repeats (hopefully soon).

Also to that point, use of terms sounding in function are permitted in MORE than 112(f). This is another critical point that you never seem to want to grasp.

Your version of reality vis a vis Written Description would take more than a blog post to address, so I will just note that this is another area that we will have to agree to disagree (at the moment). You retreat to your hobby horse of bow/gun, to which a standard reply of “the Ladders of Abstraction always have more than two rungs” defeats. That you don’t understand this defeat is something that you will have to (eventually) come to grasp with on your own.

“Taking one working species, immediately expanding it to its utility, and then writing a specification where the working species is an example embodiment of a genus defined by the utility is not a new trick, and it has been consistently rebuffed for 150 years.”

Wrong – in AT LEAST the universal way that you are trying to state the maxim. I invite you to read Klusky’s book on claim writing (and — again — to understand the concept of the Ladders of Abstraction). Your errant view can be directly tied to you lack of understanding of that concept and your desire to see ONLY ladders with two rungs.

And lastly (in an anticlimactic manner), your “Well it should go without saying that it is damaging to your client to tell the court that your client did not actually posit the defendant’s embodiment until after the critical date.” AGAIN misses the point here. It is NOT legal error to be truthful to the court on a point that is brought before the court. AGAIN, you put out there a misdirection (bad attorney) when the REAL point is one of possession at time of filing and that how PHARMA has this as an endemic issue. I know that you want to see this ONLY through the prism of your existing beliefs (you have an unhealthy confirmation bias problem), but you really should — especially here — take a step back and away from your beliefs and see the points as they are presented.

…as to the Wands factors, of course each side will want them to favor them as indicating that their position is better.

And of course, if one of those factors is thought to be favorable in the same reading, then both sides will agree (for obviously different reasonings).

But the point presented is MORE in regards to the fact that 6 of the 7 WERE in disagreement. Wands factors are meant to be more objective (hence their selection as factors), and the case here that SO MANY were NOT in agreement is what I provided that point for.

WHY were the other six not in agreement?
Of the other six, are some of the positions plainly ludicrous, or do both sides actually have legitimate arguments for their view of the factor?

Because level of skill can be made to cut both ways – A patentee wants high skill because that requires less effort to bridge any teaching gap. A challenger wants high skill because they know of multiple disparate techniques which cloud the way forward.

It’s ultimately a moot point. There’s caselaw that says that the Wands factors are instructive, not mandatory, and Genentech requires the specification itself to enable the novel functionality. It’s not about whether one of skill could figure out what treats Hep C, its only about whether the specification teaches them that. (Although one will notice that that standard essentially makes enablement like a suped up WD)

– is “effective amount” a quasi-‘functional‘ claim element (describing a desired result, not the ‘how” to get there)? – while certainly the claim construction indicated an “objective physical limitation,” there certainly was no single “objective physical limitation” and the “Ladder of Abstraction” used here was certainly questionable in regards to the Wands factors;

– can this be considered to be a single “means” (in the form of step-for) claim (only one action in the method: administering) – despite the preamble being taken as a limiting element, the limit does not change the nature of a method claim with but a single step, expressed as a desired result, and was not this the type of thing that “single means claim” prohibition was meant to address?;

There is structure in the claim, simply insufficient structure to achieve the functionality. That’s why the court had to discuss the number of alternatives (i.e. 7000 possible structures that would need to be tested if they perform the function) rather than simply stating that it covered all possible structures. It’s not clear to me how non-limiting the structure is, but if it results in “billions and billions” then it violates the logic of the single means claim if not the letter.

– In addition to the discussion of possession at page 21 (focusing more on the sheer number aspect), was possession of the effectiveness had at time of filing (as the term of “effectiveness” incurs the ability to pass effectively the requirements of human consumption), or is what was filed merely a ‘research plan?’

Every claim to a genus not entirely possessed can be characterized as a research plan, so yes.

Idenix “only came up with the methyl up fluoro down embodiment a year or so after the application was filed.” See J.A. 25562 (admission of Idenix’s counsel).”

Well shucks, its almost like if you don’t have a rule requiring a specification to provide an embodiment and explain every inductive leap it takes instead of just taking a max-abstraction functional claim as a starting point, this could happen in every application in which counsel is not too stu pid to blow the case. Certainly the law intends for this outcome to happen in every case where the attorney does not admit against his client’s interests.

Seriously though, this exact blog had a post entitled something like “WD Requires the specification to have some species representative of the infringers product” years ago. It’s Abbvie I want to say?

++ Does this not sound in the very idea that I have oft put forth in regards to possession discussions of Pharma patents?

It isn’t just pharma patents.

———————————-

Not sure why Greg or you think this is a watershed case. This is pretty basic 112(a). Does it just not get applied? (I can understand the consternation if it doesn’t get applied)

I think that this is mostly true, but I would like to note that “effective amount” is a phrase that occurs so often in pharma claims that I would like to make a certain distinction here.

In some pharma applications, one will see the words “effective amount” thrown in without any additional context. In those patents, I think that it fair to treat “effective amount” as a functional limitation (and construe it according to §112(f)).

One will often see “effective amount” defined in other pharma applications, however. In other words, there will be some note in the spec to the effect “as used herein, an ‘effective amount’ of the compound of Formula I signifies an amount between X mg/L and Y mg/L…” or some such. Obviously, in those contexts, “effective amount” is a structural limitation, not a functional limitation.

In any event, as you say, “effective amount” does not make the claim into a single means claim in any event. The “effective amount” limitation always occurs in the context of a combination claim. Even the claim “1. A pharmaceutically effective amount of the compound of Formula I” occurs in combination with the structural limitation “compound of Formula I.”

“Obviously, in those contexts, “effective amount” is a structural limitation, not a functional limitation.”

No.

The context of the specification does not change the use of the term in the claim — such remains functional as opposed to structural.

What you DO gain though with your distinction Greg, is that IF (and that’s a mighty big IF) one does (does NEED to) apply §112(f), then instead of an accompanying 112(a) rejection, you have some support to apply to the 112(f) aspect.

“The “effective amount” limitation always occurs in the context of a combination claim.”

Does it? This is a method claim. The claim has one method step. That single method step may have multiple elements, but such remains a single step claim.

Further – you want to turn “effective” (in selected cases to be “structural,” and then combine what is basically the very same thing of the “structural” of “Compound of Formula 1”

The single step is still the administering step OF an object. I do not think that “combination claim” is reached just because the object of a sentence is included with the verb of a sentence. Combination claim is more so more than one step (in a method), or more than one object (in one of the hard goods categories).

Re: the dissent. You’ll notice there are no citations to the statement that “A reasonable jury could have understood that subject matter that is unclaimed is irrelevant to validity under section 112.” Because that ain’t the law, and that and the claim construction issue are ridiculous flaws in the argument.

Clearly someone who is too interested in saving claims rather than coming to the right outcome. Sure the case COULD have been resolved by construing the claims differently, and that would only result in this non-infringer walking away scott free (as a non-infringer should), but the patentee didn’t want that. The patentee got the claim construction they wanted and now they lose their claim for it. It’s not the appellate’s function to save someone from their own stu pidity.

Regardless, it takes a lot of balls to write the sentence “However, a reasonable jury could have understood, as witnesses for both sides testified, that the only variants synthesized and evaluated in the ’597 patent have the structure where R1 is H, R9 is OH, R10 is H, R7 is OH, R6 is CH3, and X is oxygen” even if you ignore any procedural facts in this case. You should strip the header from a case and anyone who has even smelled a jury would tell you that this is written by an appellate judge.

Agree entirely. Judge Newman’s dissent is not up to her usual standards here. Maybe she is correct that there is some, better claim construction under which this claim would have survived enablement challenge (although that would have been cold comfort to Idenix, because Gilead’s drug would not infringe that construction), but neither party argued such a construction.

An appellate judge is not there to save parties from their own incompetence or overreach. Her job is to adjudicate the case presented to her. That is what the majority did and did well here. The dissent wandered way off the reservation.

Agree entirely. Judge Newman’s dissent is not up to her usual standards here. Maybe she is correct that there is some, better claim construction under which this claim would have survived enablement challenge (although that would have been cold comfort to Idenix, because Gilead’s drug would not infringe that construction), but neither party argued such a construction.

I’m not against a rule where the federal circuit vacates a claim construction, reinstates the claim, finds no infringement, and awards the non-infringer attorneys fees (i.e. essentially nullifies the entire litigation with a narrow claim construction now on the books) in the case where the claim construction was not substantially what the patentee asked for. But if the patentee asks for a broad scope to try and net infringers, they SHOULD lose their claim if they lack support for that scope.

To state the obvious, this wasn’t a Supreme Court case. It was Justice Story “riding circuit,” similar to a district court decision today written by a Supreme Court justice sitting by designation. But regardless, the law today couldn’t be any further away from the quoted passage.

In Eolas v. Microsoft (Fed. Cir. 2005), the Federal Circuit held that demonstration of a product in a conference room to two Sun Microsystems engineers qualified as a “public use,” because the engineers had no NDA or other confidentiality obligations. The court didn’t even say it was a jury question, they held as a matter of law that it qualified as a public use. This was a public use by a third party, not the inventor, but the public accessibility principle should be the same. Clearly temporary use “by a few persons” does not negate a public use today.

I admit that I had never heard of the “neighborly kindness” exception to the public use bar. There must have been a few interesting fact patterns exploring that space. Who is a “neighbor”? Was it truly just “kindness” or was there a quid pro quo (the “borrowed cup of sugar” exception to the exception).

In other news, I am SHOCKED to see the Re pu k-k-k-es swiftboating our servicemen and women who dare to criticize Pwezident Creamsicle.

Another example of the danger of using old cases, as a holding of no “public use” if done temporarily by neighbors with consent, or by third parties w/o consent, has not been a 102 or 103 exception for a very long time. Albeit the “experimental use” exception has been stretched in a few cases, and before the AIA there was a one year grace period.

Interesting post (…anniversary?) — juxtapose against the AIA and (admittedly quiet) Trade Secret “Public Use” without loss of ability to patent. Seems like that gambit was more of a backstop if general weakening of patents did not reach a desired level (for the Efficient Infringers).